10 Biotech Stocks Facing FDA Judgment Day

Cardiome(CRME Quote)
Drug/indication: Vernakalant for cardiac arrhythmias
FDA decision date: Oct. 18

After a hiccup with the first regulatory filing, Cardiome and its partner Astellas are waiting for the FDA review of the intravenous form of vernakalant, which will be used for patients suffering from acute irregular heart rhythms.

BioMarin(BMRN Quote)
Drug/indication: Kuvan for phenylketonuria
FDA decision date: Nov. 24

If approved, Kuvan would be the first effective treatment for patients with phenylketonuria, a digestive disorder in which people lack an enzyme required to break down a specific amino acid found in most protein-rich foods. As a result, PKU patients are required to follow a restrictive diet.